A 24-week Multicenter Double-blind Control Trial With Ursodeoxycholic Acid in Patients With Chronic Hepatitis C
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 596
- 试验地点
- 1
- 主要终点
- Alanine Aminotransferase at Baseline
研究概览
简要总结
This study is a 24-week multicenter, randomized, double-blind control trial with ursodeoxycholic acid (UDCA) in patients with chronic hepatitis C in Japan. The primary objectives of this study are to verify the superiority of efficacy of UDCA 600 or 900mg/day to that of 150mg/day and the safety of UDCA treatment.
详细描述
This study is a 24-week multicenter, randomized, double-blind control trial with ursodeoxycholic acid (UDCA) in patients with chronic hepatitis C in Japan. The primary objectives of this study are to verify the superiority of efficacy of UDCA 600 or 900mg/day to that of 150mg/day and the safety of UDCA treatment. The primary endpoint was percent changes of serum alanine aminotransferase(ALT) levels at 24-week of administration compared to pre-administration levels and secondary endpoints, serum aspartate aminotransferase(AST) and gamma-glutamyltranspeptidase(gamma-GTP) levels. Further, changes of bile acid composition and HCV-RNA levels at 24-week of administration were examined.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject must have a clinical diagnosis to apply the conservative medication for chronic hepatitis C.
- •Serum alanine aminotransferase levels measured at 4-week before the initiation of treatment must be over 61 IU/mL.
- •Subject's age must be 20 years or older.
排除标准
- •Subject who received a treatment of antiviral agents (interferon) within 20 weeks before the start of 8-week observation period
- •Subject who received a treatment of corticosteroids, immunosuppressive drugs, glycyrrhizic acid, cholestyramine or other drugs which could interfere with hepatic function during 8-week observation period.
- •Subject with decompensated cirrhosis
- •Subject infecting with other hepatic virus
- •Subject receiving a treatment for autoimmune disease, alcohol or drug-induced hepatic disorder, neoplasia, hepato-cholangiolar disease, fulminant hepatitis or peptic ulcer
- •Subject who require hospitalization for complications of the heart, kidney or pancreas
- •Alcohol intake more than 27 ml/day
- •Subject who involved in other clinical trial within 4 weeks before the start of observation period
- •Subject with a history of sensitivity to ursodeoxycholic acid or bile acid-products
研究组 & 干预措施
Ursodeoxycholic acid 150mg / day
干预措施: Ursodeoxycholic acid 150mg / day (Drug)
Ursodeoxycholic acid 600mg / day
干预措施: Ursodeoxycholic acid 600mg / day (Drug)
Ursodeoxycholic acid 900mg / day
干预措施: Ursodeoxycholic acid 900mg / day (Drug)
结局指标
主要结局
Alanine Aminotransferase at Baseline
时间窗: 0 week
Percentage Change of Alanine Aminotransferase From Baseline at Week 24
时间窗: 24 weeks (from baseline to Week 24)
Percentage change=\[(measured value at Week 24 - measured value at baseline)/measured value at baseline\]\*100
次要结局
- Aspartate Aminotransferase at Baseline(0 week)
- Percentage Change of Aspartate Aminotransferase From Baseline at Week 24(24 weeks (from baseline to Week 24))
- Gamma-glutamyl Transpeptidase at Baseline(0 week)
- Percentage Change of Gamma-glutamyl Transpeptidase From Baseline at Week 24(24 weeks (from baseline to Week 24))